PEEK Temporary Abutment 260-265-745

GUDID 00813110027948

6.5 x 4.5mm PEEK Temporary Abutment - 2.5mm Post

BICON, LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00813110027948
• NIH Device Record Key: bfac2c3a-96c7-4ddd-b15e-0668e5b8fe58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEEK Temporary Abutment
• Version Model Number: 260-265-745
• Catalog Number: 260-265-745
• Company DUNS: 945015758
• Company Name: BICON, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110027948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092035

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-07-17

On-Brand Devices [PEEK Temporary Abutment]

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• 00813110028020: 7.5 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
• 00813110028013: 6.5 x 6.5mm PEEK Temporary Abutment - 3.0mm Post
• 00813110028006: 6.5 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
• 00813110027993: PEEK 5.0 x 6.5mm Temporary Abutment - 3.0mm Post
• 00813110027986: 5.0 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
• 00813110027979: 4.0 x 6.5mm PEEK Temporary Abutment - 3.0mm Post
• 00813110027962: 4.0 x 4.5mm PEEK Temporary Abutment - 3.0mm Post
• 00813110027955: 6.5 x 6.5mm PEEK Temporary Abutment - 2.5mm Post
• 00813110027948: 6.5 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
• 00813110027931: 5.0 x 6.5mm PEEK Temporary Abutment - 2.5mm Post
• 00813110027924: 5.0 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
• 00813110027917: 4.0 x 6.5mm PEEK Temporary Abutment - 2.5mm Post
• 00813110027900: 4.0 x 4.5mm PEEK Temporary Abutment - 2.5mm Post
• 00813110027894: 5.0 x 6.5mm PEEK Temporary Abutment - 2.0mm Post
• 00813110027887: 5.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post
• 00813110027870: 4.0 x 6.5mm PEEK Temporary Abutment - 2.0mm Post
• 00813110027863: 4.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post